Quality Assurance Manager - Cell & Gene Therapy
Core
Develop, implement, and oversee the Quality Management System (QMS) for Cell and Gene Therapy (CGT) collection services, ensuring compliance with FDA regulations and industry standards to guarantee patient safety and product efficacy.
Role type
Quality Assurance Manager (Regulatory & QMS)
Builds
Centralized QMS covering donor eligibility, informed consent, apheresis/cell-collection processes, labeling, and packaging workflows.
Domain
Healthcare / Cell & Gene Therapy / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS development and implementation, FDA 21 CFR 1271/210/211 compliance, FACT-JACIE and AABB standards knowledge, audit preparation and management, SOP and work instruction creation, CAPA management, quality risk management, vendor and supply management, Chain of Identity and Custody systems, regulatory submission preparation (510(k), PMA, EU MDR), KPI definition and performance monitoring.
Preferred skills
Experience in apheresis, blood banking, or GMP/GTP environments, proficiency in eQMS platforms, cross-functional team leadership.
Technologies
eQMS platforms, MS Office suite
Responsibilities
Build and manage a fully compliant, centralized QMS; Ensure compliance with FDA and industry standards; Oversee process mapping and creation of SOPs; Lead quality risk management initiatives; Ensure robust Chain of Identity and Custody systems; Oversee training and competency management programs; Define quality metrics, KPIs, and dashboards; Lead the end-to-end preparation and filing of global regulatory submissions.
Seniority
Manager, hands-on leadership